It’s been nearly three years since the Abbott baby formula factory in Sturgis temporarily closed after bacterial contamination was found at the site. The closure, in tandem with COVID-19 supply chain disruptions, led to nationwide shortages.
Though the manufacturer has since reopened, new investigative reporting from ProPublica raises questions about the safety and cleanliness of the facility.
WKAR's Melorie Begay spoke with ProPublica journalist Heather Vogell about her reporting.
Interview Highlights
On cardboard being used as a funnel at the Sturgis facility
I spoke with several current and former workers, and what they told me was that in May of 2024, on a shift during a weekend, that an employee was seen picking up a piece of cardboard and was using it as a funnel to direct coconut oil, which is an ingredient of the formula, into a tank, this is all part of a batch of formula that is being made.
On Abbott's response to the incident
They did acknowledge that cardboard was “reactively used to prevent spilling onto the floor.” But they denied that there was a trash receptacle in the area. And they said that plant practice was to stack cardboard on a pallet nearby. But they did, at the same time acknowledge that the plant acted “outside of our quality process,” and they said that they had provided additional training for an employee who was involved.
On the Federal Food and Drug Administrations response
The FDA said very little to me. When I asked some questions ... they said that they couldn't confirm or deny whether there was any kind of inspection or investigation going on at the facility. We had learned from the workers that one worker had filed a complaint with the FDA and had received a response from someone at the FDA who was looking into it. But the FDA did say that they “take reports related to infant formula seriously and follow up as appropriate."
Interview Transcript
Melorie Begay: It’s been nearly three years since the Abbott baby formula factory in Sturgis temporarily closed after bacterial contamination was found at the site. The closure, in tandem with COVID-19 supply chain disruptions, led to nationwide shortages.
Though the manufacturer has since reopened, new investigative reporting from ProPublica raises questions about the safety and cleanliness of the facility.
ProPublica journalist Heather Vogell is here to talk about her reporting. Thanks for being here, Heather.
Heather Vogell: Thanks so much for having me on.
Begay: Your reporting highlights several instances where Abbott employees observed unsanitary practices occurring inside its Sturgis facility. One example describes the use of thrown out cardboard being used as a funnel. Can you tell us more about this incident and how concerning this is when it comes to the manufacturing of baby formula?
Vogell: So, I spoke with several current and former workers, and what they told me was that in May of 2024, on a shift during a weekend, that an employee was seen picking up a piece of cardboard and was using it as a funnel to direct coconut oil, which is an ingredient of the formula, into a tank, this is all part of a batch of formula that is being made.
And that other workers were really concerned about this because cardboard obviously is not sanitary in general, and that they [raised] complaints to their superiors about this. This was all part of a process to make an organic brand called Pure Bliss. So, it was something that consumers really have kind of a higher expectation for in terms of what's going into it.
Begay: And what has Abbott said about this?
Vogell: Abbott said a few things about this. They did acknowledge that cardboard was “reactively used to prevent spilling onto the floor.” But they denied that there was a trash receptacle in the area. And they said that plant practice was to stack cardboard on a pallet nearby. But they did, at the same time acknowledge that the plant acted “outside of our quality process,” and they said that they had provided additional training for an employee who was involved.
They also said that the batch that was involved underwent enhanced testing to make sure it was clear of microbes before being released to the public, and that all those tests came back negative.
Begay: What is the Federal Food and Drug Administration said or done about this?
Vogell: The FDA said very little to me. When I asked some questions, they did not provide a long response. Even though we sent them a very long list of questions. They said that they couldn't confirm or deny whether there was any kind of inspection or investigation going on at the facility.
We had learned from the workers that one worker had filed a complaint with the FDA and had received a response from someone at the FDA who was looking into it. But the FDA did say that they “take reports related to infant formula seriously and follow up as appropriate,” and they also said that they're committed to enhancing regulatory oversight of all infant formula manufacturers to help ensure that the industry is producing infant formula under the safest conditions possible.
Begay: Last month, the Department of Health and Human Services and the FDA announced Operation Stork Speed. It aims to bolster the safety of infant formulas. On the surface, it seems like this could be a step toward more accountability, but you've noted that there's a bit of a catch or some uncertainty about this. What could impede this effort?
Vogell: It's interesting that they're launching this effort to enhance and improve the regulatory oversight of infant formula manufacturing, or it seems that is the message that you're getting from the Operation Stork Speed announcement, but it's being done at the same time that FDA is making these major, major cuts to its workforce.
It was announced that roughly 3500 employees were losing their jobs at the FDA at the same time. So, the FDA said when it announced the cuts that it would not fire any inspectors. But CBS recently reported that 170 workers were being cut from the FDA office of inspections and investigations.
Begay: Heather Vogell is a journalist with ProPublica. Thanks for joining me, Heather.
Vogell: Thanks for having me on.
This conversation has been edited for clarity and conciseness.
